Cleared Traditional

Cadwell Apollo System

K201819 · Cadwell Industries, Inc. · Neurology

Sep 2020

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K201819 is an FDA 510(k) clearance for the Cadwell Apollo System, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on September 29, 2020, 90 days after receiving the submission on July 1, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K201819 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2020
Decision Date	September 29, 2020
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWQ — Full-montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations